Plain English Summary
Background and study aims
The aim of this study is to evaluate the safety and tooth whitening effect of a tooth whitening patch with primer.
Who can participate?
Adults over 20 years of age with tooth discolouration
What does the study involve?
The effectiveness of whitening is confirmed by attaching a tooth whitening patch with primer for 30 minutes for 10 days. Safety is checked by examining the presence or absence of side effects caused by whitening through questionnaires and oral examinations.
What are the possible benefits and risks of participating?
Possible benefits include effective tooth whitening. Possible risks include gingival (gum) irritation and tooth tingling.
Where is the study run from?
Kyungpook National University (South Korea)
When is the study starting and how long is it expected to run for?
January 2019 to October 2019
Who is funding the study?
LG Household & Health Care Research Park (South Korea)
Who is the main contact?
Jin-kyoung Kim
jkk0621@dhc.ac.kr
Trial website
Contact information
Type
Public
Primary contact
Miss Jinkyoung Kim
ORCID ID
Contact details
Department of Preventive Dentistry
School of Dentistry
Kyungpook National University
2177
Dalgubeol-daero
Jung-gu
Daegu
41940
Korea
South
+82 (0)53 660 6875
jkk0621@dhc.ac.kr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
KCT0004625
Study information
Scientific title
Clinical efficacy of bleaching patch with primer in randomized controlled trial
Acronym
CEPT
Study hypothesis
To clinically evaluate the efficacy and safety of the primer that contains taurine and self-bleaching patches containing 3.0% hydrogen peroxide.
Ethics approval
Approved 11/03/2019, Kyungpook National University Bioethics Review Committee (Department of preventive Dentistry School of Dentistry, Kyungpook National University 2177 Dalgubeol-daero, Jung-gu, Daegu 41940, Korea; +82 (0)53 2000 5430; knuiars@knu.ac.kr), ref: KNU 2019-0009
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not applicable
Condition
Tooth whitening
Intervention
This is a double-blinded randomized clinical trial that referred to the Consolidated Standards of Reporting Trials (CONSORT) 2010 guideline from design to completion.
Healthy adult applicants interested in tooth whitening are recruited through snowball sampling. The effectiveness of whitening is confirmed by attaching a patch containing 3.0% peroxide and a primer containing a mitigating component for 30 minutes for 10 days. In addition, safety is checked by examining the presence or absence of side effects caused by whitening through self-filling questionnaires and oral examinations.
When applied for at least 30 minutes with a self-whitening patch containing 3.0% peroxide, the efficacy of whitening compared to the placebo-controlled group is confirmed, and the difference between application times of 30 minutes is confirmed.
After applying the taurine-containing primer, a self-administered questionnaire completed asking about the patient's subjective symptoms and an oral examination is carried out for the side effects of whitening to confirm the clinical safety.
Total duration of intervention and follow-up: 18/03/2019 to 26/04/2019.
Intervention type
Drug
Phase
Not Applicable
Drug names
Hydrogen peroxide
Primary outcome measure
Tooth color measured using ∆L, ∆a, ∆b with Shade Eye NCC and Vita classical shade guide at baseline, 3, 5, 7 and 10 days
Secondary outcome measures
Side effects measured using questionnaire, VAS scale and oral examination before patching and after 3, 5, 7 and 10 days
Overall trial start date
14/01/2019
Overall trial end date
31/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults over 20 years of age who agree to take the test
2. People with good general health and oral health
3. A person with six maxillary anterior teeth
4. A person with similar level of discoloration of each tooth showing proper tooth discoloration
5. A person who understands the purpose of the test and is able to read and write
6. Who can follow the test procedure and follow the visit schedule
7. Persons who can follow up during the test
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
56
Total final enrolment
55
Participant exclusion criteria
1. People with inadequate dentition in the practice of tooth whitening
2. People with resin and porcelain restorations in the anterior region
3. A person who shows signs of inflammation in teeth due to dental caries or dental erosion
4. People with hypersensitivity due to gingivitis and periodontitis
5. People with excessive discolouration due to drugs and congenital anomalies
6. Those who have experienced tooth whitening in the past and have not passed 3 years
7. Women who are pregnant, breastfeeding or have a pregnancy plan during the test
8. Other diseases that may affect the efficacy and safety evaluation of the drug
9. A person who is taking or administering medication
10. People participating in other clinical trials or human attachment tests
11. Anyone who can not communicate or follow instructions
12. Those who do not qualify for the test under the judgment of the other examiners
Recruitment start date
01/03/2019
Recruitment end date
29/03/2019
Locations
Countries of recruitment
Korea, South
Trial participating centre
Kyungpook National University
Department of Preventive Dentistry
School of Dentistry
2177, Dalgubeol-daero, Jung-gu
Daegu
41940
Korea, South
Trial participating centre
Daegu Health University
Department of Dental Hygiene
15, Youngsong-ro, Buk-gu
Daegu
41453
Korea, South
Trial participating centre
Busan Public Health Policy Institute
359 World Cup-daero
Geoje 2(i)-dong
Yeonje-gu
Busan
-
Korea, South
Trial participating centre
Kyungpook National University
Department of Conservative Dentistry, School of Dentistry
2177, Dalgubeol-daero, Jung-gu
Daegu
41940
Korea, South
Trial participating centre
LG Household & Health Care Research Park
-
Seoul
-
Korea, South
Sponsor information
Organisation
Kyungpook National University
Sponsor details
Department of Preventive Dentistry
School of Dentistry
Daegu
41940
Korea
South
+82 (0)53 660 6875
jkk0621@dhc.ac.kr
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
LG Household & Health Care Research Park
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
08/09/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list